Overview

Phase II Randomized Study of Early Surgery Vs Multiple Sequential Antiepileptic Drug Therapy for Infantile Spasms Refractory to Standard Treatment

Status:
Completed

Trial end date:
1969-12-31

Target enrollment:

Participant gender:

Summary

OBJECTIVES: I. Evaluate the efficacy of surgical resection of an identifiable zone of cortical abnormality versus multiple drug therapy in children with infantile spasms refractory to standard therapy. II. Assess how infantile spasms interfere with development and whether this is partially reversible. III. Determine the predictors of good surgical outcome and whether surgery permanently controls seizures and improves development.

Phase:

Phase 2

Details

Lead Sponsor:

National Center for Research Resources (NCRR)

Collaborators:

National Institute of Neurological Disorders and Stroke (NINDS)
University of California, Los Angeles

Treatments:

Adrenocorticotropic Hormone
Carbamazepine
Nitrazepam
Pyridoxine
Valproic Acid